What is mifepristone and how does it work?

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Mifepristone is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation (70 days or
less since the first day of the last menstrual period). The approved mifepristone dosing regimen is:

On day one: 200 mg of mifepristone taken by mouth

24 to 48 hours after taking mifepristone: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient

About seven to fourteen days after taking mifepristone: follow-up with the health care provider

When did the FDA approve mifepristone for medical termination of pregnancy?

The FDA first approved Mifeprex (mifepristone) in September 2000 for medical termination of pregnancy through seven weeks gestation and this was extended to ten weeks gestation in 2016. FDA approved a generic version of Mifeprex, Mifepristone Tablets,
200 mg, in April 2019. The agency’s approval of this generic reflects the FDA’s determination that Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic
product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation. The labeling for the approved generic version of Mifeprex is consistent with the labeling for Mifeprex.

Who should not take mifepristone, in a regimen with misoprostol, for medical termination of pregnancy?

An individual should not take mifepristone, in a regimen with misoprostol, for medical termination of pregnancy if it has been more than 70 days since the first day of their last menstrual period, or if they: have an ectopic pregnancy (a pregnancy
outside of the uterus)

have problems with the adrenal glands (the glands near the kidneys)

are currently being treated with long-term corticosteroid therapy (medications)

have had an allergic reaction to mifepristone, misoprostol or similar drugs

have bleeding problems or are taking anticoagulant (blood thinning) drug products

have inherited porphyria (a rare disorder that can affect the liver and other organs)

have an intrauterine device (IUD) in place (it must be removed before taking mifepristone)

Is it safe to use mifepristone?

Yes. Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of
the scientific evidence presented and determined that it was safe and effective for its indicated use. As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation. The FDA’s periodic reviews of the postmarketing data for
Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation. As with all drugs, the FDA continues to closely monitor the postmarketing safety
data on mifepristone for the medical termination of pregnancy.
What are the possible side effects of using mifepristone for medical termination of pregnancy through ten weeks gestation?

The possible side effects are described in the Adverse Reactions section of the labeling and in the Medication Guide for mifepristone.

What serious adverse events have been reported after the use of mifepristone for medical termination of pregnancy through ten weeks gestation?

As with all approved drugs, when the FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, takes necessary action. This could include, for example, providing updates to health care providers
and their patients so that they have information on how to use a drug safely.

It is common for the FDA to receive reports of serious adverse events for prescription drugs after they are approved. Many drugs are associated with serious adverse events that are known at the time of approval and considered when the FDA makes its
approval decision. The FDA continuously reviews reports of adverse events to, among other things, determine whether they are known risks or whether they are signals of emerging safety concerns.

The FDA has received reports of serious adverse events in patients who took mifepristone. As of December 31, 2022, there were 32 reports of deaths in patients associated with mifepristone since the product was approved in September 2000, including two
cases of ectopic pregnancy (a pregnancy located outside the womb, such as in the fallopian tubes) resulting in death; and several fatal cases of severe systemic infection (also called sepsis). The adverse events cannot with certainty be causally
attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of
adverse events that reflects data through December 31, 2022, is here. The FDA has reviewed thisinformation and did not identify any new safety signals. The FDA intends to update this summary report as appropriate.

What should health care providers watch for in patients who have taken mifepristone for medical termination of pregnancy through ten weeks gestation?

Health care providers should review the approved labeling for Mifeprex and the approved generic, Mifepristone Tablets, 200 mg. The signs and symptoms they should watch for are included in the labeling, available here.

What is an ectopic pregnancy?

An ectopic pregnancy is a non-viable pregnancy that develops outside of the womb. It occurs in two percent of all pregnancies. An ectopic pregnancy is usually located in one of the fallopian tubes. As the fetus grows, the tube cannot hold it, causing the
tube to rupture (burst) and bleed. Unless they are discovered and treated early, almost 40 percent of ectopic pregnancies rupture suddenly, causing pain and bleeding in the abdominal cavity. The other 60 percent usually cause slow bleeding in the abdomen.
Ruptured ectopic pregnancies can be fatal. The approved labeling for Mifeprex and the approved generic, Mifepristone Tablets, 200 mg, states that the use of mifepristone, in a regimen with misoprostol, for the medical termination of pregnancy through
ten weeks gestation is contraindicated in patients with confirmed or suspected ectopic pregnancy.Does the FDA endorse this drug product

The FDA does not endorse any drug product. The agency evaluates all drug applications submitted by applicants to determine whether the data and information in an application support the approval of the application. The same standards are applied to the
drug applications for Mifeprex and the approved generic Mifepristone Tablets, 200 mg, as are applied to all drug applications.

The Mifepristone REMS Program
Why is there a REMS for this product?

The FDA’s determination as to whether a REMS is necessary for a particular drug is a drug-specific evaluation. The agency considers whether (based on premarketing or postmarketing risk assessments) there is a particular risk or risks associated with
the use of the drug that, on balance, outweigh its benefits and whether additional risk mitigation measures beyond the FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks.

The goal of the Mifepristone REMS Program is to mitigate the risk of serious complications associated with mifepristone when used for medical termination of pregnancy through ten weeks gestation by, among other things, requiring that prescribers have the
necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only
dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.

Does the FDA endorse this drug product

The FDA does not endorse any drug product. The agency evaluates all drug applications submitted by applicants to determine whether the data and information in an application support the approval of the application. The same standards are applied to the
drug applications for Mifeprex and the approved generic Mifepristone Tablets, 200 mg, as are applied to all drug applications.

The Mifepristone REMS Program
Why is there a REMS for this product?

The FDA’s determination as to whether a REMS is necessary for a particular drug is a drug-specific evaluation. The agency considers whether (based on premarketing or postmarketing risk assessments) there is a particular risk or risks associated with
the use of the drug that, on balance, outweigh its benefits and whether additional risk mitigation measures beyond the FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks.

The goal of the Mifepristone REMS Program is to mitigate the risk of serious complications associated with mifepristone when used for medical termination of pregnancy through ten weeks gestation by, among other things, requiring that prescribers have the
necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only
dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.Does the FDA endorse this drug product

The FDA does not endorse any drug product. The agency evaluates all drug applications submitted by applicants to determine whether the data and information in an application support the approval of the application. The same standards are applied to the
drug applications for Mifeprex and the approved generic Mifepristone Tablets, 200 mg, as are applied to all drug applications.

The Mifepristone REMS Program
Why is there a REMS for this product?

The FDA’s determination as to whether a REMS is necessary for a particular drug is a drug-specific evaluation. The agency considers whether (based on premarketing or postmarketing risk assessments) there is a particular risk or risks associated with
the use of the drug that, on balance, outweigh its benefits and whether additional risk mitigation measures beyond the FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks.

The goal of the Mifepristone REMS Program is to mitigate the risk of serious complications associated with mifepristone when used for medical termination of pregnancy through ten weeks gestation by, among other things, requiring that prescribers have the
necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only
dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.Does the FDA endorse this drug product

The FDA does not endorse any drug product. The agency evaluates all drug applications submitted by applicants to determine whether the data and information in an application support the approval of the application. The same standards are applied to the
drug applications for Mifeprex and the approved generic Mifepristone Tablets, 200 mg, as are applied to all drug applications.

The Mifepristone REMS Program
Why is there a REMS for this product?

The FDA’s determination as to whether a REMS is necessary for a particular drug is a drug-specific evaluation. The agency considers whether (based on premarketing or postmarketing risk assessments) there is a particular risk or risks associated with
the use of the drug that, on balance, outweigh its benefits and whether additional risk mitigation measures beyond the FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks.

The goal of the Mifepristone REMS Program is to mitigate the risk of serious complications associated with mifepristone when used for medical termination of pregnancy through ten weeks gestation by, among other things, requiring that prescribers have the
necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only
dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.


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